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FDA Comes Out Against Aspirin for Primary Prevention — Physician’s First Watch

FDA Comes Out Against Aspirin for Primary Prevention

By Larry Husten

Aspirin shouldn't be marketed for primary prevention of heart attack or stroke, the FDA has announced. The statement follows the agency's rejection on Friday of Bayer Healthcare's decade-old petition requesting approval of a primary prevention indication.

Aspirin is still widely used for primary prevention. The American Heart Association currently supports its use for primary prevention when recommended by a physician in high-risk patients. (There is widespread agreement that for secondary prevention, aspirin's benefits outweigh the risks, and it should be used to prevent a second heart attack or stroke after an earlier cardiovascular event.)

In its statement, the FDA said it had "reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain."

Like many other countries, Indian practitioners too are very often guided by some received "medical traditions". I am afraid this could be the most formidable hindrance to change the paradigm of practice. Moreover, alternatives to paracetamol to control pain and fever should be critically and clearly stated. Finally, how much evidence is there so as not to prescribe 500 mg of paracetamol for the fear of hepatic failure is not quite convincing.

When questioned about primary prevention patients taking Asa often take it without ever discussing it with their doctor and have never been formally prescribed it and simply take it over the counter as it seems entrenched in our psychic it is a good thing to you

Big Pharma?? Really? This shows how little residents know about business or medicine. Take a look around a pharmacy. The generics dominate by far in 81mg ECASA.
Since my patients having acute mi's, over 25 years of running emergency departments, seemed to start around 40 years of age, I start there at pushing for daily 81mg ECASA. I do NOT care what the politically correct FDA or other statistical engine site might say. The cost is miniscule. There is no significant side effect outside of the rare individuals WITH other risk factors unless you can show me a cheap test for berry aneurysms.

Aspirin side effects are very common and become more obvious with age. Twice I have seen intracranial hemorrhage attributed to aspirin. Often dysypepsia and vague bloating and malaise and not uncommonly a PPI is prescribed for this.

Not to long ago my best friend, a neurosurgery resident at a prestigious program, who happens to be exactly my same age (actually a month younger, 33 this year) asked me what did I think about him starting to take a daily aspirin for primary prevention of MI, stroke and colorectal cancer. I discouraged him to do so. He is young and other than having the worst quality of life in terms of sleep, diet and exercise, he is a very healthy dude. There are no data available to date to justify taking a daily pill for the rest of his life. These type of interventions are the ones that bring healthcare cost up, not only for the person taking the "supplements" or aspirin or any other compound that has not shown evidence, but for everybody else as well. The only reason to take a daily aspirin in these days is for secondary prophylaxis after MI and stroke. Data from a large trial published in the journal last week (POISE-2) show that aspirin prophylaxis around surgery is deleterious and increases the risk of bleeding without any additional benefit in terms of CVD prevention. The fact that is a cheap intervention should not justify it, as it may cost ten cents per day but if you multiply that for a lifelong therapy for millions of healthy individuals, the expenditure is outstanding. Don't let pharma full you on this one, no data in these cases should mean to you "stay away from the drug" not "lets keep trying it, the cost is little and there may be some benefit".

Although the reasoning underlying the FDA's opinion on aspirin use as primary prevention of myocardial infarction and stroke seems sound, it is not entirely clear why this opinion needed to be voiced. Of the host of over-the-counter drugs available for casual use by the average American citizen, aspirin seems among the most innocuous. Yes, it has obvious potential side effects -- and no, the optimum safe dose for effective primary prevention of vascular catastrophe in the "average" American is hardly clear. But an opinion voiced by the FDA that there is no support for and that there are dangerous side effects associated with its general use for this purpose may make it difficult for physicians to recommend it to patients for whom it may be useful and safe. The decision underscores the importance of a larger issue: the remarkable availability of any number of compounds (dietary supplements, OTC remedies for all manner of minor ailments, food items with purported "healing" properties, etc.) to any American with the financial resources to indulge in such use. I see little need for this proclamation and an unfortunated potential avoidance of aspirin's use in those individuals for whom it may be of primary benefit when recommended by a knowledgeable physician.

Is this a medical decision or a political one? How can an inexpensive, widely available remedy be safe for prevention of a second heart attack, but not for prevention of a first one? I'm going with the American Heart Association guidelines.

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